Department of Health and Human Services 2011 – Federal Register Recent Federal Regulation Documents

Results 1 - 200 of 3,846
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2011-33599
Type: Notice
Date: 2011-12-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2011-33597
Type: Notice
Date: 2011-12-30
Agency: Department of Health and Human Services, National Institutes of Health
Medical Devices; Ovarian Adnexal Mass Assessment Score Test System; Labeling; Black Box Restrictions
Document Number: 2011-33588
Type: Rule
Date: 2011-12-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the regulation classifying ovarian adnexal mass assessment score test systems to restrict these devices so that a prescribed warning statement that addresses a risk identified in the special controls guidance document must be in a black box and must appear in all labeling, advertising, and promotional material. The black box warning mitigates the risk to health associated with off-label use as a screening test, stand-alone diagnostic test, or as a test to determine whether or not to proceed with surgery.
Request for Nominations of Candidates To Serve on the Advisory Committee on Breast Cancer in Young Women (ACBCYW)
Document Number: 2011-33576
Type: Notice
Date: 2011-12-30
Agency: Department of Health and Human Services, Centers for Disease Control and Prevention (cdc)
Food and Drug Administration Transparency Initiative: Food and Drug Administration Report on Good Guidance Practices: Improving Efficiency and Transparency; Availability
Document Number: 2011-33573
Type: Notice
Date: 2011-12-30
Agency: Food and Drug Administration, Department of Health and Human Services
As part of the Transparency Initiative, the Food and Drug Administration (FDA or Agency) is announcing the availability of a report entitled ``Food and Drug Administration Report on Good Guidance Practices: Improving Efficiency and Transparency.'' This report was prepared in response to Action Item 11 in the Phase III Report (FDA Transparency Initiative: Improving Transparency to Regulated Industry, dated January 2011). In that action item, the Commissioner of Food and Drugs (the Commissioner), Dr. Margaret A. Hamburg, called for a cross- Agency working group to prepare a report identifying FDA's ``best practices'' and making recommendations to streamline the development of guidance documents, reduce the time between issuing draft and final guidance documents, and make it easier to find guidance documents on FDA's Web site.
Guidance for Industry: Current Good Tissue Practice and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products; Availability
Document Number: 2011-33572
Type: Notice
Date: 2011-12-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)'' dated December 2011. The guidance document provides recommendations to establishments for complying with CGTP and additional requirements for manufacturers of HCT/Ps. The guidance is intended for any HCT/P establishment that performs a manufacturing step and is responsible for complying with CGTP requirements. The guidance also addresses whether the establishment registration and HCT/P listing requirements apply in certain instances. The guidance announced in this notice finalizes the draft guidance of the same title dated January 2009.
Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting
Document Number: 2011-33561
Type: Notice
Date: 2011-12-30
Agency: Food and Drug Administration, Department of Health and Human Services
Agency Information Collection Activities; Proposed Collection; Comment Request; Revisions to Labeling Requirements for Blood and Blood Components, Including Source Plasma
Document Number: 2011-33555
Type: Notice
Date: 2011-12-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on certain labeling requirements for blood and blood components, including Source Plasma. These requirements will facilitate the use of a labeling system using machine-readable information that would be acceptable as a system for labeling blood and blood components, and the use of new labeling systems that may be developed in the future. Additionally, these requirements are issued to help ensure the continued safety of the blood supply and facilitate consistency in labeling.
Draft Guidance for Industry on Use of Histology in Biomarker Qualification Studies; Availability
Document Number: 2011-33553
Type: Notice
Date: 2011-12-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Use of Histology in Biomarker Qualification Studies.'' This guidance is intended to assist sponsors that conduct biomarker qualification studies for which histology is a reference standard. This guidance discusses the processes that should be considered to ensure the quality and integrity of histology data in biomarker studies, and outlines the scientific standards for histology used in biomarker characterization and qualification. The recommendations in this guidance are intended for studies in biomarker qualification designated to justify the proposed context of use, where scientifically rigorous evaluation of biomarker performance in relation to histologic changes is essential. The principles outlined in this guidance are also applicable to exploratory biomarker studies.
Oncologic Drugs Advisory Committee; Notice of Meeting
Document Number: 2011-33552
Type: Notice
Date: 2011-12-30
Agency: Food and Drug Administration, Department of Health and Human Services
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices: Humanitarian Use Devices
Document Number: 2011-33551
Type: Notice
Date: 2011-12-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Draft Guidance for Industry on Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices; Availability
Document Number: 2011-33550
Type: Notice
Date: 2011-12-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices.'' This draft guidance responds to stakeholder requests for specific guidance on FDA's current views on how manufacturers and distributors (firms) of prescription human and animal drug products and medical devices can respond to unsolicited requests for information about unapproved or uncleared indications or conditions of use (off- label information) related to their FDA-approved or cleared products. This draft guidance updates and clarifies FDA's policies on unsolicited requests for off-label information, including those that firms may encounter through emerging electronic media.
Determination That HYCODAN (Hydrocodone Bitartrate and Homatropine Methylbromide) Tablets, 5 Milligrams/1.5 Milligrams, and HYCODAN (Hydrocodone Bitartrate and Homatropine Methylbromide) Oral Solution, 5 Milligrams/5 Milliliters and 1.5 Milligrams/5 Milliliters, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2011-33549
Type: Notice
Date: 2011-12-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined that HYCODAN (hydrocodone bitartrate and homatropine methylbromide) tablets, 5 milligrams (mg)/1.5 mg, and HYCODAN (hydrocodone bitartrate and homatropine methylbromide) oral solution, 5 mg/5 milliliters (mL) and 1.5 mg/5 mL, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for hydrocodone bitartrate and homatropine methylbromide tablets, 5 mg/1.5 mg, and HYCODAN (hydrocodone bitartrate and homatropine methylbromide) oral solution, 5 mg/5 mL and 1.5 mg/5 mL, if all other legal and regulatory requirements are met.
Oncologic Drugs Advisory Committee; Notice of Meeting
Document Number: 2011-33548
Type: Notice
Date: 2011-12-30
Agency: Food and Drug Administration, Department of Health and Human Services
Clinical Laboratory Improvement Advisory Committee (CLIAC)
Document Number: 2011-33388
Type: Notice
Date: 2011-12-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2011-33497
Type: Notice
Date: 2011-12-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2011-33496
Type: Notice
Date: 2011-12-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting
Document Number: 2011-33494
Type: Notice
Date: 2011-12-29
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2011-33492
Type: Notice
Date: 2011-12-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2011-33491
Type: Notice
Date: 2011-12-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Meeting
Document Number: 2011-33489
Type: Notice
Date: 2011-12-29
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2011-33484
Type: Notice
Date: 2011-12-29
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2011-33483
Type: Notice
Date: 2011-12-29
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2011-33481
Type: Notice
Date: 2011-12-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2011-33479
Type: Notice
Date: 2011-12-29
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Request. 30-Day Public Comment Request
Document Number: 2011-33391
Type: Notice
Date: 2011-12-29
Agency: Department of Health and Human Services
Agency Information Collection Request 30-Day Public Comment Request
Document Number: 2011-33390
Type: Notice
Date: 2011-12-29
Agency: Department of Health and Human Services
Ophthalmic and Topical Dosage Form New Animal Drugs; Ivermectin Topical Solution
Document Number: 2011-33382
Type: Rule
Date: 2011-12-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Cross Vetpharm Group, Ltd. The supplemental ANADA adds claims for persistent effectiveness against various species of external and internal parasites when cattle are treated with a topical solution of ivermectin.
Privacy Act; System of Records
Document Number: 2011-33346
Type: Notice
Date: 2011-12-29
Agency: Department of Health and Human Services, Office of Inspector General
In accordance with the Privacy Act of 1974, as amended, the Office of Inspector General gives notice of a proposed amendment to its Privacy Act system of records entitled ``Consolidated Data Repository'' (09-90-1000). This system of records is being amended to include records regarding Federal and State benefit programs and service providers in Federal health care programs.
Solicitation of New Safe Harbors and Special Fraud Alerts
Document Number: 2011-33345
Type: Proposed Rule
Date: 2011-12-29
Agency: Department of Health and Human Services, Office of Inspector General
In accordance with section 205 of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), this annual notice solicits proposals and recommendations for developing new and modifying existing safe harbor provisions under the Federal anti-kickback statute (section 1128B(b) of the Social Security Act), as well as developing new OIG Special Fraud Alerts.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Study on Consumer Responses to Nutrition Facts Labels With Various Footnote Formats and Declaration of Amount of Added Sugars
Document Number: 2011-33303
Type: Notice
Date: 2011-12-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2011-33293
Type: Notice
Date: 2011-12-29
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``MEPS Cancer Self Administrated Questionnaire.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on November 2nd, 2011 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.
Request for Measures and Domains To Use in Development of a Standardized Instrument for Use in Public Reporting of Family Experience of Pediatric Inpatient Care
Document Number: 2011-33290
Type: Notice
Date: 2011-12-29
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
Section 401(a) of the Children's Health Insurance Program Reauthorization Act of 2009 (CHIPRA), Public Law 111-3, amended the Social Security Act (the Act) to enact section 1139A (42 U.S.C. 1320b- 9a). Section 1139A(b) charged the Department of Health and Human Services with improving pediatric health care quality measures. The Agency for Healthcare Research and Quality (AHRQ) is soliciting the submission of instruments or domains (for example, key concepts) measuring aspects of families' experience with the quality of inpatient medical and surgical hospital care from all researchers, vendors, hospitals, stakeholders, and other interested parties. The survey development team of Children's Hospital Boston Center of Excellence for Pediatric Quality Measurement (CEPQM), is one of the CHIPRA Pediatric Quality Measures Program (PQMP) Centers of Excellence, which were created pursuant to an interagency agreement between the Centers for Medicare & Medicaid Services (CMS) and AHRQ, and are funded through cooperative agreement awards with AHRQ. AHRQ is interested in instruments and items through which families of pediatric patients assess the care their child receives during the child's inpatient stay. The goal is to develop a standardized instrument for use in the public reporting of family experience of pediatric inpatient care. The team developing this survey intends to submit it to the CAHPS Consortium to request use of the CAHPS trademark. The survey will be developed in accordance with CAHPS Survey Design Principles and will develop implementation instructions based on those for CAHPS instruments (https://www.cahps.AHRQ.gov/About-CAHPS/Principles.aspx.) All CAHPS surveys are available to users free of charge and are published on the AHRQ Web site.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2011-33321
Type: Notice
Date: 2011-12-28
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection: Comment Request
Document Number: 2011-33295
Type: Notice
Date: 2011-12-28
Agency: Department of Health and Human Services, Health Resources and Services Administration
National Advisory Council on the National Health Service Corps; Notice of Meeting
Document Number: 2011-33294
Type: Notice
Date: 2011-12-28
Agency: Department of Health and Human Services, Health Resources and Services Administration
Guidance for Industry: Prevention of Salmonella
Document Number: 2011-33292
Type: Notice
Date: 2011-12-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation.'' The document provides guidance to egg producers on how to comply with certain provisions contained in FDA's final rule ``Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation'' (the final rule), including how to implement Salmonella Enteritidis (SE) prevention measures, how to sample for SE., and how to maintain records documenting compliance with the final rule.
Administration on Children, Youth and Families; Statement of Organization, Functions, and Delegations of Authority
Document Number: 2011-33265
Type: Notice
Date: 2011-12-28
Agency: Department of Health and Human Services, Administration for Children and Families
Statement of Organizations, Functions, and Delegations of Authority The Administration for Children and Families (ACF) has reorganized the Administration on Children, Youth and Families (ACYF). This reorganization realigns the Children's Bureau Data and Technology Team and the Family and Youth Services Bureau Research, Data, and Evaluation Team to create the Office of Data Analysis, Research, and Evaluation. It also renames the Division of Research and Innovation to the Division of Program Innovation. It renames the Division of Youth Services to the Division of Adolescent Development and Support. It deletes the Division of Abstinence Programs. Additionally, it deletes the Mentoring Children of Prisoners program.
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2011-33251
Type: Notice
Date: 2011-12-28
Agency: Department of Health and Human Services, National Institutes of Health
Draft Guidance for Industry and Food and Drug Administration Staff; the 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]; Availability
Document Number: 2011-33232
Type: Notice
Date: 2011-12-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Draft Guidance for Industry and Food and Drug Administration Staff; The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)].'' FDA developed this draft guidance document to provide a contemporary perspective on how FDA reviews premarket notification (510(k)) submissions as well as on the Special and Abbreviated 510(k) programs. This guidance addresses the major aspects of the 510(k) decision-making process and updates FDA's policies with respect to the Special and Abbreviated 510(k) programs. This draft guidance is not final nor is it in effect at this time.
Draft Guidance for Industry and Food and Drug Administration Staff; Center for Devices and Radiological Health Appeals Processes; Availability
Document Number: 2011-33230
Type: Notice
Date: 2011-12-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Center for Devices and Radiological Health (CDRH) Appeals Processes.'' This document describes the processes available to outside stakeholders to request additional review of decisions and actions by CDRH employees. The document also provides general information about each process as well as guidance on how to submit related requests to CDRH and FDA. This draft guidance is not final nor is it in effect at this time.
Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting
Document Number: 2011-33220
Type: Notice
Date: 2011-12-28
Agency: Food and Drug Administration, Department of Health and Human Services
Submission for OMB Review; Comment Request
Document Number: 2011-33192
Type: Notice
Date: 2011-12-28
Agency: Department of Health and Human Services, Administration for Children and Families
Communications and Activities Related to Off-Label Uses of Marketed Products and Use of Products Not Yet Legally Marketed; Request for Information and Comments
Document Number: 2011-33188
Type: Notice
Date: 2011-12-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the establishment of a docket to assist with our evaluation of our policies on communications and activities related to off-label uses of marketed products, as well as communications and activities related to use of products that are not yet legally marketed for any use, we would like to obtain comments and information related to scientific exchange. FDA is interested in obtaining comments and information regarding scientific exchange about both unapproved new uses of products already legally marketed (``off-label'' use) and use of products not yet legally marketed for any use.
Temperature-Indicating Devices; Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers; Correction
Document Number: 2011-33183
Type: Rule
Date: 2011-12-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of Thursday, March 3, 2011 (76 FR 11892). The final rule amended FDA's regulations for thermally processed low-acid foods packaged in hermetically sealed containers to allow for use of other temperature-indicating devices, in addition to mercury-in-glass thermometers, during processing. The final rule was published with one error. This document corrects that error.
Draft Guidance for Industry and Food and Drug Administration Staff; Investigational Device Exemptions for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human Studies; Extension of Comment Period
Document Number: 2011-33142
Type: Notice
Date: 2011-12-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is extending the comment period for the notice that appeared in the Federal Register of Thursday, November, 10, 2011 (76 FR 70150). In the notice, FDA requested comments on the draft guidance that addresses the approaches FDA intends to facilitate early feasibility studies of medical devices, using appropriate risk mitigation strategies, under the investigational device exemption (IDE) requirements. The Agency is taking this action to allow interested persons additional time to submit comments.
Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff; Food and Drug Administration Decisions for Investigational Device Exemption (IDE) Clinical Investigations; Extension of Comment Period
Document Number: 2011-33141
Type: Notice
Date: 2011-12-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is extending the comment period for the notice that appeared in the Federal Register of Thursday, November, 10, 2011 (76 FR 70151). In the notice, FDA requested comments on the draft guidance that has been developed to promote the initiation of clinical investigations to evaluate the medical devices under FDA's Investigational Device Exemptions (IDE) regulations. The Agency is taking this action to allow interested persons additional time to submit comments.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application
Document Number: 2011-33140
Type: Notice
Date: 2011-12-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the FDA guidance for industry on ``Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application.'' This guidance document provides recommendations on postmarketing serious adverse event reporting for nonprescription (over-the-counter) human drugs marketed without an approved application. It provides recommendations on the minimum data elements that should be included in a serious adverse event report, the label that should be included with the report, reporting formats for paper and electronic submissions, and how and where to submit the reports.
National Institute of Environmental Health Sciences; Notice of Meeting
Document Number: 2011-33138
Type: Notice
Date: 2011-12-27
Agency: Department of Health and Human Services, National Institutes of Health
National Library of Medicine Notice of Meeting
Document Number: 2011-33137
Type: Notice
Date: 2011-12-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Disorders; Notice of Closed Meeting
Document Number: 2011-33136
Type: Notice
Date: 2011-12-27
Agency: Department of Health and Human Services, National Institutes of Health
Center For Scientific Review; Notice of Closed Meeting
Document Number: 2011-33135
Type: Notice
Date: 2011-12-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2011-33134
Type: Notice
Date: 2011-12-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental & Craniofacial Research; Notice of Meeting
Document Number: 2011-33133
Type: Notice
Date: 2011-12-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2011-33132
Type: Notice
Date: 2011-12-27
Agency: Department of Health and Human Services, National Institutes of Health
Prospective Grant of Exclusive License: Use of Methanocarba Analogues of Purine and Pyrimidine Nucleosides and Nucleotides to Treat or Prevent Cardiac Diseases in Humans
Document Number: 2011-33131
Type: Notice
Date: 2011-12-27
Agency: Department of Health and Human Services, National Institutes of Health
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of a worldwide exclusive evaluation option license, to practice the inventions embodied in U.S. Provisional Patent Application No. 60/ 176,373, filed January 14, 2000 and currently abandoned [HHS Ref. No. E-176-1999/0-US-01]; PCT Application PCT/US01/00981, filed January 12, 2001 and currently expired [HHS Ref. No. E-176-1999/0-PCT-02]; U.S. Patent Application No. 10/169,975, filed July 12, 2002 and issued as U.S. Patent No. 7,087,589 on August 8, 2006 [HHS Ref. No. E-176-1999/0- US-06]; U.S. Patent Application No. 11/500,860, filed August 8, 2006 and issued as U.S. Patent No. 7,790,735 on September 14, 2006 [HHS Ref. No. E-176-1999/0-US-07]; Australian Patent Application No. 2001230913, filed January 12, 2001 and issued as Australian Patent No. 2001230913 on October 13, 2005 [HHS Ref. No. E-176-1999/0-AU-03]; Canadian Patent Application No. 2,397,366, filed January 12, 2001 and issued as Canadian Patent No. 2,397,366 on March 15, 2011 [HHS Ref. No. E-176- 1999/0-CA-04]; European Patent Application No. 01903043.6, filed January 12, 2001 and issued as European Patent No. 1252160 on August 6, 2006 and currently abandoned [HHS Ref. No. E-176-1999/0-EP-05]; and UK Patent Application No. 01903043.6, filed January 12, 2001 and issued as UK Patent No. 1252160 on August 16, 2006 [HHS Ref. No. E-176-1999/0-GB- 08], entitled ``Methanocarba Cycloalkyl Nucleoside Analogues'' to Cornovus Pharmaceuticals, Inc., a company incorporated under the laws of the State of Delaware having its headquarters in Farmington, Connecticut. The United States of America is the assignee of the rights of the above inventions. The prospective exclusive evaluation option license territory may be ``worldwide'', and the field of use may be limited to ``The use of (1'S,2R,3S,4'R,5'S)-4- (6-amino-2-chloro-9H-purin-9-yl)-1-[phosphoryloxymethyl] bicycle[3.1.0]hexane-2,3-diol) (MRS2339) to treat and/or prevent cardiac diseases in humans.'' Upon the expiration or termination of the exclusive evaluation option license, Cornovus Pharmaceuticals, Inc. will have the right to execute an exclusive patent commercialization license which will supersede and replace the exclusive evaluation option license with no greater field of use and territory than granted in the evaluation license.
Request for Nominations for Voting Members on a Public Advisory Committee; Food Advisory Committee
Document Number: 2011-33108
Type: Notice
Date: 2011-12-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is requesting nominations for members with expertise in epidemiology, pediatric development, and analytical chemistry or food science to serve on the Food Advisory Committee, Center for Food Safety and Applied Nutrition, Office of Regulations, Policy, and Social Sciences. FDA has a special interest in ensuring that women, minority groups, and individuals with disabilities are adequately represented on advisory committees and, therefore, encourages nominations of qualified candidates from these groups.
Request for Nominations of Candidates To Serve on the Advisory Committee on Breast Cancer in Young Women (ACBCYW)
Document Number: 2011-33092
Type: Notice
Date: 2011-12-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Request for Nominations for Voting Members on Public Advisory Panels or Committees
Document Number: 2011-33060
Type: Notice
Date: 2011-12-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the Device Good Manufacturing Practice Advisory Committee, certain device panels of the Medical Devices Advisory Committee, and the National Mammography Quality Assurance Advisory Committee in the Center for Devices and Radiological Health. Nominations will be accepted for current vacancies and those that will or may occur through December 31, 2012. FDA has a special interest in ensuring that women, minority groups, and individuals with disabilities are adequately represented on advisory committees and, therefore, encourages nominations of qualified candidates from these groups.
Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting
Document Number: 2011-33059
Type: Notice
Date: 2011-12-27
Agency: Food and Drug Administration, Department of Health and Human Services
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2011-32837
Type: Notice
Date: 2011-12-22
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery
Document Number: 2011-32834
Type: Notice
Date: 2011-12-22
Agency: Department of Health and Human Services, National Institutes of Health
As part of a Federal Government-wide effort to streamline the process to seek feedback from the public on service delivery, NIMH has submitted a Generic Information Collection Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery'' to OMB for approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.).
Agency Recordkeeping/Reporting Requirements Under Emergency Review by the Office of Management and Budget (OMB)
Document Number: 2011-32824
Type: Notice
Date: 2011-12-22
Agency: Department of Health and Human Services, Administration for Children and Families
Bristol-Myers Squibb Co. et al.; Withdrawal of Approval of 70 New Drug Applications and 97 Abbreviated New Drug Applications; Correction
Document Number: 2011-32822
Type: Notice
Date: 2011-12-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of June 8, 2011 (76 FR 33310). The document announced the withdrawal of approval of 70 new drug applications (NDAs) and 97 abbreviated new drug applications (ANDAs) from multiple applicants, effective July 8, 2011. The document indicated that FDA was withdrawing approval of the following three ANDAs after receiving a request from the ANDA holder, A.H. Robins Co., c/o Wyeth Pharmaceuticals, Inc., P.O. Box 8299, Philadelphia, PA 19101- 8299: ANDA 086661, DONNATAL (phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine (HBr)) Elixir; ANDA 086676, DONNATAL (phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine (HBr)) Tablets; and ANDA 086677, DONNATAL (phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine (HBr)) Capsules. Before withdrawal of these ANDAs became effective, PBM Pharmaceuticals, Inc., acquired the rights to the ANDAs and informed FDA that it did not want them withdrawn. Because the basis for withdrawal would have been a request from the ANDA holder and the request was timely withdrawn, the approval of ANDAs 086661, 086676, and 086677 is still in effect.
HIT Policy Committee Advisory Meeting; Notice of Meeting
Document Number: 2011-32792
Type: Notice
Date: 2011-12-22
Agency: Department of Health and Human Services
Privacy Act of 1974; System of Records Notice
Document Number: 2011-32791
Type: Notice
Date: 2011-12-22
Agency: Department of Health and Human Services, Office of the Secretary
In accordance with the requirements of the Privacy Act of 1974, HHS/OS/ONC is establishing a new system of records, ``ONC Health IT Dashboard,'' to create datasets that will be used by ONC and its partners (including grantees in the Health IT Extension Center program and ONC program evaluation contractors) to assess, improve, and publicize the effectiveness of ONC health IT grants to States and State-designated entities. The datasets will enable ONC to (1) Evaluate the state of health IT implementation by parties registered to receive (i.e., who have received or could receive) electronic health record implementation assistance from ONC grantees, (2) compare the evaluations to grantees' progress reports in order to validate claims submitted for grant payments, (3) share the evaluations with the grantees to help improve grant performance, and (4) make aggregate data (e.g., national and State-level implementation estimates) publicly available on ONC's Web site at https://www.healthit.hhs.gov. The parties receiving grants and health IT implementation assistance from ONC grantees include health care providers (not only provider-entities such as hospitals, but individual providers such as individual physicians), community colleges, State-designated entities, and other entities. Information about an individual provider (e.g., an individual physician as opposed to a hospital, corporation or other organization) is protected by the Privacy Act. Privacy Act-protected information about each individual provider will consist of the provider's health IT implementation information, demographic information, and contact information, retrieved by his or her National Provider Identifier (NPI). The system will not contain information about patients. The system of records is more thoroughly described in the Supplementary Information section and System of Records Notice (SORN), below.
HIT Standards Committee Advisory Meeting; Notice of Meeting
Document Number: 2011-32790
Type: Notice
Date: 2011-12-22
Agency: Department of Health and Human Services
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donor Testing, Donor Notification, and “Lookback”
Document Number: 2011-32778
Type: Notice
Date: 2011-12-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Blood Establishment Registration and Product Listing, Food and Drug Administration Form 2830
Document Number: 2011-32777
Type: Notice
Date: 2011-12-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees
Document Number: 2011-32776
Type: Notice
Date: 2011-12-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the collection of information concerning the establishment and operation of clinical trial data monitoring committees.
Withdrawal of Notices of Opportunity for a Hearing; Penicillin and Tetracycline Used in Animal Feed
Document Number: 2011-32775
Type: Notice
Date: 2011-12-22
Agency: Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is withdrawing two 1977 notices of opportunity for a hearing (NOOH), which proposed to withdraw certain approved uses of penicillin and tetracyclines intended for use in feeds for food-producing animals based in part on microbial food safety concerns.\1\ (Refs. 1 and 2) FDA is taking this action, and closing the corresponding dockets, because: FDA is engaging in other ongoing regulatory strategies developed since the publication of the 1977 NOOHs with respect to addressing microbial food safety issues; FDA would update the NOOHs to reflect current data, information, and policies if, in the future, it decides to move forward with withdrawal of the approved uses of the new animal drugs described in the NOOHs; and FDA would need to prioritize any withdrawal proceedings (for example, take into account which withdrawal(s) would likely have the most significant impact on the public health) if, in the future, it decides to seek withdrawal of the approved uses of any new animal drug or class of drugs. FDA is also withdrawing the companion proposed rules to these NOOHs. (Refs. 3 and 4)
Agency Information Collection Request. 30-Day Public Comment Request
Document Number: 2011-32729
Type: Notice
Date: 2011-12-22
Agency: Department of Health and Human Services
Nexira; Filing of Food Additive Petition
Document Number: 2011-32542
Type: Proposed Rule
Date: 2011-12-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that Nexira has filed a petition proposing that the food additive regulations be amended to provide for the expanded safe use of acacia gum (gum arabic) in food.
Oral Dosage Form New Animal Drugs; Cyclosporine
Document Number: 2011-32526
Type: Rule
Date: 2011-12-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Novartis Animal Health US, Inc. The NADA provides for the veterinary prescription use of cyclosporine oral solution, USP (MODIFIED) for the control of feline allergic dermatitis.
Center for Scientific Review Notice of Closed Meetings
Document Number: 2011-32520
Type: Notice
Date: 2011-12-20
Agency: Department of Health and Human Services, National Institutes of Health
Medicare and Medicaid Programs; Announcement of Application From Hospital Requesting Waiver for Organ Procurement Service Area
Document Number: 2011-32503
Type: Notice
Date: 2011-12-20
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice with comment period announces a waiver request from Pioneer Community Hospital to participate in an Organ Procurement Organization (OPO) outside of its designated OPO. The request was made in accordance with section 1138(a)(2) of the Social Security Act (the Act) which provides that a hospital may obtain a waiver from the Secretary under certain conditions. This notice solicits comments from OPOs and the general public for our consideration in determining whether we should grant the requested waiver.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2011-32497
Type: Notice
Date: 2011-12-20
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2011-32495
Type: Notice
Date: 2011-12-20
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Information Collection Activity; Comment Request
Document Number: 2011-32489
Type: Notice
Date: 2011-12-20
Agency: Department of Health and Human Services, Administration for Children and Families
Advisory Committees; Tentative Schedule of Meetings for 2012
Document Number: 2011-32469
Type: Notice
Date: 2011-12-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a tentative schedule of forthcoming meetings of its public advisory committees for 2012. During 1991, at the request of the Commissioner of Food and Drugs (the Commissioner), the Institute of Medicine (the IOM) conducted a study of the use of FDA's advisory committees. In its final report, one of the IOM's recommendations was for the Agency to publish an annual tentative schedule of its meetings in the Federal Register. This publication implements the IOM's recommendation.
Establishing Timeframes for Implementation of Product Safety Labeling Changes; Request for Comments
Document Number: 2011-32438
Type: Notice
Date: 2011-12-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is seeking comments on specific issues related to its authority under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to require or order safety labeling changes for approved prescription drug products based on new safety information that becomes available after a drug product is approved. The FD&C Act specifies the timeframes within which a safety labeling change must be submitted when required or ordered by the FDA, and timeframes for FDA to conclude its review and take regulatory action regarding safety labeling changes. FDA's regulations also provide procedures by which labeling changes that do not qualify as changes based on new safety information can be requested by FDA or by the holder of the drug approval. FDA is seeking public input to assist the Agency in establishing specific timeframes for implementing both types of labeling changes.
Guidance for Industry and Food and Drug Administration Staff; Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology Devices; Availability
Document Number: 2011-32437
Type: Notice
Date: 2011-12-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology Devices.'' This document describes FDA's intent with regard to enforcement of premarket notification (510(k)) requirements for certain in vitro diagnostic and radiology devices under the regulations.
Food and Drug Administration Rare Disease Patient Advocacy Day; Notice of Meeting
Document Number: 2011-32436
Type: Notice
Date: 2011-12-20
Agency: Food and Drug Administration, Department of Health and Human Services
Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice; Public Workshop
Document Number: 2011-32435
Type: Notice
Date: 2011-12-20
Agency: Food and Drug Administration, Department of Health and Human Services
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2011-32459
Type: Notice
Date: 2011-12-19
Agency: Department of Health and Human Services, National Institutes of Health
National Library of Medicine; Notice of Meetings
Document Number: 2011-32429
Type: Notice
Date: 2011-12-19
Agency: Department of Health and Human Services, National Institutes of Health
National Library of Medicine; Notice of Meetings
Document Number: 2011-32426
Type: Notice
Date: 2011-12-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2011-32425
Type: Notice
Date: 2011-12-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2011-32424
Type: Notice
Date: 2011-12-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2011-32422
Type: Notice
Date: 2011-12-19
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Information Collection Activity; Comment Request
Document Number: 2011-32410
Type: Notice
Date: 2011-12-19
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Information Collection Activities; Proposed Collection; Comment Request; Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products
Document Number: 2011-32397
Type: Notice
Date: 2011-12-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of FDA's requirements on content and format of labeling for human prescription drug and biological products.
Correction for Draft Vieques Report: An Evaluation of Environmental, Biological, and Health Data From the Island of Vieques, PR
Document Number: 2011-32371
Type: Notice
Date: 2011-12-19
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
On December 12, 2011 the Agency for Toxic Substance and Disease Register published a 30-day public comment period notice in the Federal Register (76 FR 77234) for the Draft Vieques Report: An Evaluation of Environmental, Biological, and Health Data From the Island of Vieques, Puerto Rico.'' This comment period was published as closing on January 11, 2012 in error. The comment period will be open for 90 days and will close March 11, 2012.
Draft Guidance for Industry and Food and Drug Administration Staff; Evaluation of Sex Differences in Medical Device Clinical Studies; Availability
Document Number: 2011-32368
Type: Notice
Date: 2011-12-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Evaluation of Sex Differences in Medical Device Clinical Studies.'' This document provides guidance on the study and evaluation of sex differences in medical device clinical trials, with a specific focus on addressing potential differences in study design, conduct, outcomes, and interpretation that should be considered to ensure sex-specific issues are adequately addressed in clinical trials. This draft guidance is not final nor is it in effect at this time.
Determination that Bretylium Tosylate Injection, 50 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2011-32367
Type: Notice
Date: 2011-12-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined that Bretylium Tosylate injection, 50 milligrams (mg)/milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for Bretylium Tosylate injection, 50 mg/mL, if all other legal and regulatory requirements are met.
Applications for Food and Drug Administration Approval To Market a New Drug; Revision of Postmarketing Reporting Requirements-Discontinuance
Document Number: 2011-32354
Type: Rule
Date: 2011-12-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is issuing an interim final rule amending its postmarketing reporting regulations implementing certain provisions of the Federal Food, Drug and Cosmetic Act. The provisions of the Federal Food, Drug and Cosmetic Act require manufacturers who are the sole manufacturers of certain drug products to notify FDA at least 6 months before discontinuance of manufacture of the products. This interim final rule modifies the term ``discontinuance'' and clarifies the term ``sole manufacturer'' with respect to notification of discontinuance requirements. The broader reporting resulting from these changes will enable FDA to improve its collection and distribution of drug shortage information to physician and patient organizations and to work with manufacturers and other stakeholders to respond to potential drug shortages.
Agency Recordkeeping/Reporting Requirements Under Emergency Review by the Office of Management and Budget (OMB)
Document Number: 2011-32349
Type: Notice
Date: 2011-12-19
Agency: Department of Health and Human Services, Administration for Children and Families
Solicitation of Nominations for Membership on the Secretary's Advisory Committee on Human Research Protections
Document Number: 2011-32326
Type: Notice
Date: 2011-12-19
Agency: Department of Health and Human Services
The Office for Human Research Protections (OHRP), a program office in the Office of the Assistant Secretary for Health, Department of Health and Human Services (HHS), is seeking nominations of qualified candidates to be considered for appointment as members of the Secretary's Advisory Committee on Human Research Protections (SACHRP). SACHRP provides advice and recommendations to the Secretary, HHS, and the Assistant Secretary for Health on matters pertaining to the continuance and improvement of functions within the authority of HHS directed toward protections for human subjects in research. SACHRP was established by the Secretary, HHS, on October 1, 2002. OHRP is seeking nominations of qualified candidates to fill four positions on the Committee membership that will be vacated during the 2012 calendar year.
Webinar Overview of the National Vaccine Advisory Committee Healthcare Personnel Influenza Vaccination Subgroup's Draft Report and Draft Recommendations for Achieving the Healthy People 2020 Annual Coverage Goals for Influenza Vaccination in Healthcare Personnel
Document Number: 2011-32319
Type: Notice
Date: 2011-12-19
Agency: Department of Health and Human Services
The National Vaccine Program Office (NVPO), on behalf of the National Vaccine Advisory Committee (NVAC), Healthcare Personnel Influenza Vaccination Subgroup (HCPIVS), will host an informational webinar to introduce the committee's draft report and draft recommendations for annually achieving 90% influenza vaccination coverage among healthcare personnel, as stated in the Healthy People 2020 goals. The informational webinar provides an opportunity for the public to listen to an overview of the findings and processes used by the HCPIVS members to derive their recommendations. Pre-registration for the webinar is required. The co-chairs of the HCPIVS working group will also provide information to the public on how to submit written comments on the draft report and draft recommendations through the Federal Register process. Registrants for the webinar will be provided an opportunity to submit questions about the report at the time of registration. Public and Stakeholder comments on the draft report and the draft recommendations should be directed to https://www.hhs.gov/ nvpo/nvac/subgroups/healthcare_personnel_influenza_vacc_ subgroup.html.
Solicitation of Written Comments on the Draft Report and Draft Recommendations of the Healthcare Personnel Influenza Vaccination Subgroup for Consideration by the National Vaccine Advisory Committee on Achieving the Healthy People 2020 Annual Coverage Goals for Influenza Vaccination in Healthcare Personnel
Document Number: 2011-32308
Type: Notice
Date: 2011-12-19
Agency: Department of Health and Human Services
The National Vaccine Advisory Committee (NVAC) was established in 1987 to comply with Title XXI of the Public Health Service Act (Pub. L. 99-660) (Sec. 2105) (42 U.S. Code 300aa-5 (PDF78 KB)). Its purpose is to advise and make recommendations to the Director of the National Vaccine Program on matters related to program responsibilities. The Assistant Secretary for Health (ASH) has been designated by the Secretary of Health and Human Services as the Director of the National Vaccine Program. The ASH has charged the NVAC with developing recommended strategies for annually achieving 90% influenza vaccination coverage among healthcare personnel, as stated in the Healthy People 2020 goals. The Healthcare Personnel Influenza Vaccination Subgroup (HCPIVS), a subgroup of the NVAC Adult Immunization Working Group (AWIG), was established to address this charge on behalf of the NVAC. A draft report and draft recommendations have been developed by the HCPIVS for consideration by the NVAC and will be deliberated on by the NVAC when developing NVAC's final recommendations to the ASH. The National Vaccine Program Office (NVPO) is soliciting public comment on the Healthcare Personnel Influenza Vaccination Subgroup draft report and draft recommendations for increasing vaccination of healthcare personnel to meet the Healthy People 2020 goals. Individuals and organizations are encouraged to submit their comments on the draft report and draft recommendations. It is anticipated that the draft report and draft recommendations, as revised with consideration given to public comment and stakeholder input, will be presented in February 2012 to the NVAC for deliberation and decision on their final recommendations.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Examination of Online Direct-to-Consumer Prescription Drug Promotion
Document Number: 2011-32275
Type: Notice
Date: 2011-12-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Medicare, Medicaid, Children's Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests
Document Number: 2011-32244
Type: Proposed Rule
Date: 2011-12-19
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would require applicable manufacturers of drugs, devices, biologicals, or medical supplies covered by Medicare, Medicaid or the Children's Health Insurance Program (CHIP) to report annually to the Secretary certain payments or transfers of value provided to physicians or teaching hospitals (``covered recipients''). In addition, applicable manufacturers and applicable group purchasing organizations (GPOs) are required to report annually certain physician ownership or investment interests. The Secretary is required to publish applicable manufacturers' and applicable GPOs' submitted payment and ownership information on a public Web site.
Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review; Proposed Rule
Document Number: 2011-32361
Type: Proposed Rule
Date: 2011-12-16
Agency: Department of Health and Human Services
On October 3, 2011, the Centers for Disease Control (CDC), located within the Department of Health and Human Services (HHS) published a Notice of Proposed Rulemaking (NPRM) in the Federal Register (76 FR 61206) requesting public comment on the appropriateness of the current HHS and Overlap list of select agents and toxins including whether there are other agents or toxins that should be added to the HHS or Overlap list or whether agents or toxins currently on the HHS or Overlap list should be deleted from the list; the appropriateness of the proposed tiering of the select agents and toxins list; whether minimum standards for personnel reliability, physical and cyber security should be prescribed for identified Tier 1 agents; and any other aspect of the proposed amendments to the select agent regulations. The comment period closed on December 2, 2011. Since we would like to allow interested persons additional time to prepare and submit comments, we are reopening the comment period for the NPRM.
Advisory Committee on Childhood Lead Poisoning Prevention (ACCLPP)
Document Number: 2011-32346
Type: Notice
Date: 2011-12-16
Agency: Department of Health and Human Services, Centers for Disease Control and Prevention (cdc)
Center For Scientific Review; Notice of Closed Meeting
Document Number: 2011-32314
Type: Notice
Date: 2011-12-16
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2011-32309
Type: Notice
Date: 2011-12-16
Agency: Department of Health and Human Services, National Institutes of Health
Center For Scientific Review; Notice of Closed Meeting
Document Number: 2011-32306
Type: Notice
Date: 2011-12-16
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Meeting
Document Number: 2011-32304
Type: Notice
Date: 2011-12-16
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases Notice of Closed Meeting
Document Number: 2011-32300
Type: Notice
Date: 2011-12-16
Agency: Department of Health and Human Services, National Institutes of Health
Medicare Program; First Semi-Annual Meeting of the Advisory Panel on Hospital Outpatient Payment (HOP-Formerly Known as the Advisory Panel on Ambulatory Payment Classification Groups-APC Panel)-February 27, 28, and 29, 2012
Document Number: 2011-32298
Type: Notice
Date: 2011-12-16
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the first semi-annual meeting of the Advisory Panel on Hospital Outpatient Payment (HOP), formerly known as the Advisory Panel on Ambulatory Payment Classification Groups (the APC Panel) for 2012. The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services (DHHS) (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) (the Administrator) on the clinical integrity of the APC groups and their associated weights, and hospital outpatient supervision issues.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2011-32296
Type: Notice
Date: 2011-12-16
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2011-32294
Type: Notice
Date: 2011-12-16
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2011-32290
Type: Notice
Date: 2011-12-16
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Proposed Information Collection Activity; Comment Request
Document Number: 2011-32242
Type: Notice
Date: 2011-12-16
Agency: Department of Health and Human Services, Administration for Children and Families
Ophthalmic and Topical Dosage Form New Animal Drugs; Hydrocortisone Aceponate, Miconazole Nitrate, and Gentamicin Sulfate Otic Suspension
Document Number: 2011-32226
Type: Rule
Date: 2011-12-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) filed by Virbac AH, Inc. The NADA provides for the veterinary prescription use of a hydrocortisone aceponate, miconazole nitrate, and gentamicin sulfate suspension for the treatment of otitis externa in dogs.
Oral Dosage Form New Animal Drugs; Estriol
Document Number: 2011-32214
Type: Rule
Date: 2011-12-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) filed by Intervet, Inc. The NADA provides for the veterinary prescription use of estriol tablets for the control of estrogen-responsive urinary incontinence in ovariohysterectomized female dogs.
Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting
Document Number: 2011-32206
Type: Notice
Date: 2011-12-16
Agency: Food and Drug Administration, Department of Health and Human Services
Pediatric Advisory Committee; Notice of Meeting
Document Number: 2011-32205
Type: Notice
Date: 2011-12-16
Agency: Food and Drug Administration, Department of Health and Human Services
Organ Procurement and Transplantation Network
Document Number: 2011-32204
Type: Proposed Rule
Date: 2011-12-16
Agency: Department of Health and Human Services
This notice of proposed rulemaking sets forth the Secretary's proposal to include vascularized composite allografts, described below, within the definition of organs covered by the rules governing the operation of the Organ Procurement and Transplantation Network. The Secretary further proposes a corresponding change to the definition of human organs covered by section 301 of the National Organ Transplant Act of 1984, as amended.
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2011-32203
Type: Notice
Date: 2011-12-16
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2011-32202
Type: Notice
Date: 2011-12-16
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2011-32201
Type: Notice
Date: 2011-12-16
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-July Through September 2011
Document Number: 2011-32107
Type: Notice
Date: 2011-12-16
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from July through September 2011, relating to the Medicare and Medicaid programs and other programs administered by CMS.
National Institute of Dental and Craniofacial Research; Notice of Closed Meetings
Document Number: 2011-32194
Type: Notice
Date: 2011-12-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2011-32192
Type: Notice
Date: 2011-12-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2011-32191
Type: Notice
Date: 2011-12-15
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Research Resources; Notice of Closed Meetings
Document Number: 2011-32189
Type: Notice
Date: 2011-12-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: 2011-32188
Type: Notice
Date: 2011-12-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Meeting
Document Number: 2011-32186
Type: Notice
Date: 2011-12-15
Agency: Department of Health and Human Services, National Institutes of Health
Announcing the Award of a Single-Source Grant to Support Services for Haitian Medical Evacuees to the Florida Department of Children and Families in St. Petersburg, FL
Document Number: 2011-32168
Type: Notice
Date: 2011-12-15
Agency: Department of Health and Human Services, Office of Refugee Resettlement
Notice is hereby given that a single-source grant of $220,000 was awarded to Florida Department of Children and Families, located in St. Petersburg, FL, by the Administration for Children and Families, Office of Refugee Resettlement. Award funds will provide medical and supportive social services to Haitian medical evacuees affected by the earthquake in 2010. The Haitian medical evacuees were brought to the United States (U.S.) in the aftermath of the earthquake in Haiti on January 12, 2010. This is a population that arrived in the U.S. with significant medical issues and no available system for ongoing medical and supportive social services. They had sustained a wide range of injuries, including burns, crush injuries, and head and spine injuries. During Fiscal Year 2010, the refugees' medical costs for their first 8 months in Florida totaled $6.2 million. The single-source award will provide urgently needed support to this group, which are currently residing in a tent complex in St. Petersburg, FL.
Agency Information Collection Request. 30-Day Public Comment Request
Document Number: 2011-32123
Type: Notice
Date: 2011-12-15
Agency: Department of Health and Human Services
Agency Emergency Information Collection Clearance Request for Public Comment
Document Number: 2011-32118
Type: Notice
Date: 2011-12-15
Agency: Department of Health and Human Services
National Cancer Institute; Notice of Closed Meeting
Document Number: 2011-32104
Type: Notice
Date: 2011-12-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: 2011-32112
Type: Notice
Date: 2011-12-14
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2011-32109
Type: Notice
Date: 2011-12-14
Agency: Department of Health and Human Services, National Institutes of Health
Availability of Draft NTP Technical Reports; Request for Comments; Announcement of a Public Meeting To Peer Review Draft NTP Technical Reports
Document Number: 2011-32106
Type: Notice
Date: 2011-12-14
Agency: Department of Health and Human Services
The NTP announces the availability of seven draft NTP Technical Reports (TRs) tentatively scheduled for peer review by an NTP Technical Reports Peer-Review Panel at a meeting on February 8-9, 2012. The meeting is open to the public with time scheduled for oral public comment. The NTP also invites written comments on the draft reports (see ``Request for Comments'' below). Information about this meeting, including draft reports and preliminary agenda, will be available on the NTP Web site (https://ntp.niehs.nih.gov/go/36051). Summary minutes from the peer review will be posted on the NTP Web site following the meeting.
Proposed Information Collection Activity; Comment Request
Document Number: 2011-32051
Type: Notice
Date: 2011-12-14
Agency: Department of Health and Human Services, Administration for Children and Families
Scientific Information Request on Intravascular Diagnostic and Imaging Medical Devices
Document Number: 2011-32048
Type: Notice
Date: 2011-12-14
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from manufacturers of intravascular diagnostic and imaging medical devices, including: Fractional Flow Reserve (FFR), Coronary Flow Reserve (CFR), Intravascular Ultrasound (IVUS), Intravascular Ultrasound (VH-IVUS) with Virtual Histology, Optical Coherent Tomography (OCT), Near- Infrared Spectroscopy (NIR), Angioscopy, Intravascular Magnetic Resonance Imaging (MRI), Elastrography, and Thermography. Scientific information is being solicited to inform our Comparative Effectiveness Review of Intravascular Diagnostic Procedures and Imaging Techniques versus Angiography Alone, which is currently being conducted by the Evidence-based Practice Centers for the AHRQ Effective Health Care Program. Access to published and unpublished pertinent scientific information on this device will improve the quality of this comparative effectiveness review. AHRQ is requesting this scientific information and conducting this comparative effectiveness review pursuant to Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108-173.
Scientific Information Request on CYP2C19 Variants and Platelet Reactivity Tests
Document Number: 2011-32047
Type: Notice
Date: 2011-12-14
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from manufacturers of CYP2C19 variants and platelet reactivity tests. Scientific information is being solicited to inform our Comparative Effectiveness Review of Testing of CYP2C19 Variants and Platelet Reactivity for Guiding Antiplatelet Treatment, which is currently being conducted by the Evidence-based Practice Centers for the AHRQ Effective Health Care Program. Access to published and unpublished pertinent scientific information on this device will improve the quality of this comparative effectiveness review. AHRQ is requesting this scientific information and conducting this comparative effectiveness review pursuant to Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108-173.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2011-32027
Type: Notice
Date: 2011-12-14
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study on the Public Display of Lists of Harmful and Potentially Harmful Tobacco Constituents
Document Number: 2011-32026
Type: Notice
Date: 2011-12-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish a notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on the Experimental Study on the Public Display of the List of Harmful and Potentially Harmful Tobacco Constituents. This study is being conducted in support of the provision of the Family Smoking Prevention and Tobacco Control Act (the Tobacco Control Act) that requires FDA to publish in a format that is understandable and not misleading to a lay person and to place on public display the list of harmful and potentially harmful constituents (HPHCs) in tobacco products and tobacco smoke.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body
Document Number: 2011-32025
Type: Notice
Date: 2011-12-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Statement of Organization, Functions and Delegations of Authority
Document Number: 2011-32015
Type: Notice
Date: 2011-12-14
Agency: Department of Health and Human Services, Health Resources and Services Administration
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2011-32014
Type: Notice
Date: 2011-12-14
Agency: Department of Health and Human Services, Health Resources and Services Administration
Quantitative Summary of the Benefits and Risks of Prescription Drugs: A Literature Review
Document Number: 2011-31931
Type: Notice
Date: 2011-12-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft report entitled ``Quantitative Summary of the Benefits and Risks of Prescription Drugs: A Literature Review'' (literature review report). A literature review was conducted to address a requirement of the Patient Protection and Affordable Care Act (Affordable Care Act). FDA is publishing the literature review report to allow the public to provide comment on the report as it relates to the Affordable Care Act.
Clinical Center; Notice of Meeting
Document Number: 2011-31929
Type: Notice
Date: 2011-12-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Meeting
Document Number: 2011-31927
Type: Notice
Date: 2011-12-13
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Meeting
Document Number: 2011-31926
Type: Notice
Date: 2011-12-13
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2011-31925
Type: Notice
Date: 2011-12-13
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2011-31923
Type: Notice
Date: 2011-12-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2011-31922
Type: Notice
Date: 2011-12-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: 2011-31921
Type: Notice
Date: 2011-12-13
Agency: Department of Health and Human Services, National Institutes of Health
Early Retiree Reinsurance Program
Document Number: 2011-31920
Type: Notice
Date: 2011-12-13
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces that CMS, based on the projected availability of funding under the Early Retiree Reinsurance Program (ERRP), is exercising its authority under the ERRP regulations at 45 CFR 149.45(a) to deny ERRP reimbursement requests, in their entirety, that include claims that are incurred after December 31, 2011. Therefore, plan sponsors must not include such claims in their Claim Lists and Summary Cost Data submitted in support of a reimbursement request. Should circumstances related to the availability of ERRP funding change, CMS may issue a new notice announcing approval of ERRP reimbursement request that include claims incurred after December 31, 2011.
Board of Scientific Counselors, National Center for Injury Prevention and Control: Notice of Charter Renewal
Document Number: 2011-31896
Type: Notice
Date: 2011-12-13
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Information Collection Activities; Comment Request
Document Number: 2011-31876
Type: Notice
Date: 2011-12-13
Agency: Department of Health and Human Services, Administration of Children and Families
Proposed Information Collection Activity; Comment Request
Document Number: 2011-31872
Type: Notice
Date: 2011-12-13
Agency: Department of Health and Human Services, Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Document Number: 2011-31871
Type: Notice
Date: 2011-12-13
Agency: Department of Health and Human Services, Administration for Children and Families
Draft Guidance for Industry and Food and Drug Administration Staff on Humanitarian Use Device Designations; Availability
Document Number: 2011-31867
Type: Notice
Date: 2011-12-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and FDA staff entitled ``Humanitarian Use Device (HUD) Designations.'' Devices are eligible for HUD designation if they are designed to treat or diagnose a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year. Devices that receive HUD designation may be eligible for marketing approval under the Humanitarian Device Exemption (HDE) marketing pathway. This guidance document is intended to assist applicants in the preparation and submission of HUD designation requests and FDA reviewers in evaluating such requests.
Patient Protection and Affordable Care Act; Establishment of Consumer Operated and Oriented Plan (CO-OP) Program
Document Number: 2011-31864
Type: Rule
Date: 2011-12-13
Agency: Department of Health and Human Services
This final rule implements the Consumer Operated and Oriented Plan (CO-OP) program, which provides loans to foster the creation of consumer-governed, private, nonprofit health insurance issuers to offer qualified health plans in the Affordable Insurance Exchanges (Exchanges). The goal of this program is to create a new CO-OP in every State in order to expand the number of health plans available in the Exchanges with a focus on integrated care and greater plan accountability.
Agency Information Collection Request. 60-Day Public Comment Request
Document Number: 2011-31848
Type: Notice
Date: 2011-12-13
Agency: Department of Health and Human Services
Family and Youth Services Bureau; Proposed Information Collection Activity; Comment Request
Document Number: 2011-31703
Type: Notice
Date: 2011-12-13
Agency: Department of Health and Human Services, Administration for Children and Families
National Institute of Environmental Health Sciences; Notice of Meeting
Document Number: 2011-31842
Type: Notice
Date: 2011-12-12
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Meeting
Document Number: 2011-31839
Type: Notice
Date: 2011-12-12
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Nursing Research; Notice of Closed Meetings
Document Number: 2011-31837
Type: Notice
Date: 2011-12-12
Agency: Department of Health and Human Services, National Institutes of Health
Office of Biotechnology Activities, Office of Science Policy, Office of the Director; Notice of Meeting
Document Number: 2011-31833
Type: Notice
Date: 2011-12-12
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Meetings
Document Number: 2011-31832
Type: Notice
Date: 2011-12-12
Agency: Department of Health and Human Services, National Institutes of Health
National Library of Medicine; Notice of Closed Meeting
Document Number: 2011-31831
Type: Notice
Date: 2011-12-12
Agency: Department of Health and Human Services, National Institutes of Health
Submission for OMB Review; Comment Request; The SSA-NIH Collaboration to Improve the Disability Determination Process: Validation of IRT-CAT Tools
Document Number: 2011-31828
Type: Notice
Date: 2011-12-12
Agency: Department of Health and Human Services, National Institutes of Health
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Clinical Research Center, the National Institutes of Health has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register, September 8, 2011, Volume 76, Number 174, page 55690, and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. Potential persons who are to respond to the collection of information are not required to respond to the collection of information unless it displays a currently valid OMB control number. Proposed Collection: Title: The SSA-NIH Collaboration to Improve the Disability Determination Process: Validation of IRT-CAT tools. Type of Information Collection Request: NEW. Need and Use of Information Collection: The Epidemiology and Biostatistics section in RMD will be collecting information through a contractor (Boston University- Health and Disability Research Institute (BU-HDR)) and subcontractor for validation of the Computer Adaptive Tests which are being developed to assist in the SSA disability determination process. The utilization of CAT technology could potentially allow the SSA to collect more relevant and precise data about human functioning in a faster, more efficient fashion. To validate the CAT assessments that have been developed, the contractor will administer both the BU-HDR CAT and established legacy instruments in a small sample of adults who report their current employment status as ``permanently disabled''. Individuals will complete the CAT tools for the functional domains of Physical Demands and Interpersonal Interactions along with established legacy instruments. For the domain of physical function, individuals will complete the BU-HDR CAT; the PROMIS Item Bank v 1.0-Physical Functioning (copyright) PROMIS Health Organization and PROMIS Cooperative Group; and, The Short Form (36) Health SurveyTM (SF-36). For the domain of interpersonal interactions, individuals will complete the BU-HDR CAT, the SF-36 and the BASIS-24(copyright) (Behavior and Symptom Identification Scale). Data collected will be used to validate the BU-HDR CAT tools. Without this information, completion of the BU-HDR CAT tools will not be possible. Frequency of Response: Once. Affected Public: Individuals who have opted in to participate in web surveys through a survey research firm. Type of Respondents: Adults who indicate ``permanently disabled'' as a working status. The annual reporting burden is as follows:
National Library of Medicine; Notice of Closed Meetings
Document Number: 2011-31818
Type: Notice
Date: 2011-12-12
Agency: Department of Health and Human Services, National Institutes of Health
Subcommittee on Procedures Review, Advisory Board on Radiation and Worker Health (ABRWH), National Institute for Occupational Safety and Health (NIOSH)
Document Number: 2011-31793
Type: Notice
Date: 2011-12-12
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Board of Scientific Counselors, Office of Public Health Preparedness and Response: Notice of Charter Renewal
Document Number: 2011-31787
Type: Notice
Date: 2011-12-12
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
U.S. National Authority for the WHO Global Code of Practice on the International Recruitment of Health Personnel; Notice of Public Meeting
Document Number: 2011-31775
Type: Notice
Date: 2011-12-12
Agency: Department of Health and Human Services, Health Resources and Services Administration
In order to support the United States' implementation of the WHO Global Code of Practice on the International Recruitment of Health Personnel, notice is hereby given of the following meeting to update and engage interested parties in U.S. implementation efforts.
Availability of Draft Vieques Report: An Evaluation of Environmental, Biological, and Health Data From the Island of Vieques, Puerto Rico
Document Number: 2011-31770
Type: Notice
Date: 2011-12-12
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
This notice announces the availability of the Draft Vieques Report: An Evaluation of Environmental, Biological, and Health Data from the Island of Vieques, Puerto Rico for review and comment. This report's principal focus is to review updated environmental data on Vieques air, water, soil, seafood, and locally grown foods. In addition, this report evaluates human biomonitoring and health outcome data. ATSDR is providing a public comment period for this draft report as a means to best serve public health and the residents of Vieques, Puerto Rico. The Draft Vieques Report is available in English and Spanish at www.regulations.gov in the docket identified by Docket ID No. CDC-2011- 0014 and www.atsdr.cdc.gov/sites/vieques/.
Proposed Information Collection Activity; Comment Request
Document Number: 2011-31597
Type: Notice
Date: 2011-12-12
Agency: Department of Health and Human Services, Administration for Children and Families
National Cancer Institute; Notice of Closed Meetings
Document Number: 2011-31679
Type: Notice
Date: 2011-12-09
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2011-31622
Type: Notice
Date: 2011-12-09
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
New Animal Drugs for Use in Animal Feeds; Tilmicosin
Document Number: 2011-31613
Type: Rule
Date: 2011-12-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Elanco Animal Health, a division of Eli Lilly & Co. The supplemental NADA provides for use of tilmicosin Type C medicated feeds by veterinary feed directive for the control of bovine respiratory disease in groups of beef and nonlactating dairy cattle.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Study of Comparative Direct-to-Consumer Advertising
Document Number: 2011-31609
Type: Notice
Date: 2011-12-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Notice of Listing of Members of the Food and Drug Administration's Senior Executive Service Performance Review Board
Document Number: 2011-31579
Type: Notice
Date: 2011-12-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is publishing a list of members who may be named to serve on FDA's Senior Executive Performance Review Board or Panels, which oversee the evaluation of performance appraisals of FDA's Senior Executive Service (SES) members. The Civil Service Reform Act of 1978 requires that the appointment of Performance Review Board Members be published in the Federal Register.
Proposed Information Collection Activity; Comment Request
Document Number: 2011-31572
Type: Notice
Date: 2011-12-09
Agency: Department of Health and Human Services, Administration for Children and Families
Generic Drug User Fee; Public Meeting
Document Number: 2011-31630
Type: Notice
Date: 2011-12-08
Agency: Food and Drug Administration, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2011-31562
Type: Notice
Date: 2011-12-08
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2011-31561
Type: Notice
Date: 2011-12-08
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Prospective Grant of Exclusive License: Use of Agents Targeting Thrombospondin-1 and CD47 To Treat Radiation-Induced Damage and Enhance the Effectiveness of Radiotherapy in Cancer Patients
Document Number: 2011-31556
Type: Notice
Date: 2011-12-08
Agency: Department of Health and Human Services, National Institutes of Health
This is a notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of a worldwide exclusive license, to practice the inventions embodied in U.S. Provisional Patent Application No. 60/850,132, filed October 6, 2006, now abandoned (HHS Ref. No. E-227-2006/0-US-01); U.S. Provisional Patent Application No. 60/864,153, filed November 02, 2006, now abandoned (HHS Ref. No. E-227-2006/1-US-01); U.S. Provisional Patent Application No. 60/888,754, filed February 07, 2007, now abandoned (HHS Ref. No. E-227-2006/2-US-01); U.S. Provisional Patent Application No. 60/910,549, filed April 06, 2007, now abandoned (HHS Ref. No. E-227-2006/3-US-01); U.S. Provisional Patent Application No. 60/956,375, filed August 16, 2007, now abandoned (HHS Ref. No. E-227- 2006/4-US-01); PCT Patent Application No. PCT/2007/080647, filed October 5, 2007, now abandoned (HHS Ref. No. E-227-2006/5-PCT-01); U.S. Patent Application No. 12/444,364, filed April 3, 2009 (HHS Ref. No. E- 227-2006/5-US-02); Canadian Patent Application No. 2,665,287, filed October 5, 2007 (HHS Ref. No. E-227-2006/5-CA-03); Australian Patent Application No. 2007319576, filed October 5, 2007 (HHS Ref. No. E-227- 2006/5-AU-04); European Patent Application No. 07868382.8, filed October 5, 2007 (HHS Ref. No. E-227-2006/5-EP-05); U.S. Provisional Patent Application No. 61/086,991, filed August 7, 2008, now abandoned (HHS Ref. No. E-153-2008/0-US-01); PCT Patent Application No. PCT/2009/ 052902, filed August 5, 2009, now abandoned (HHS Ref. No. E-153-2008/0- PCT-02); U.S. Patent Application No. 13/057,447, filed February 3, 2011 (HHS Ref. No. E-153-2008/0-US-06); Canadian Patent Application No. 2732102 filed August 5, 2009 (HHS Ref. No. E-153-2008/0-CA-043); Australian Patent Application No. 2009279676, filed August 5, 2009 (HHS Ref. No. E-153-2008/0-AU-03); and European Patent Application No. 09791202.6, filed August 5, 2009 (HHS Ref. No. E-153-2008/0-EP-08), entitled ``Prevention of Tissue Ischemia, Related Methods and Compositions,'' and ``Radioprotectants Targeting Thrombospondin-1 and CD47,'' to Radiation Control Technologies, Inc., a company incorporated under the laws of the State of Delaware having its headquarters in Rockville, Maryland. The United States of America is the assignee of the rights of the above inventions. The prospective exclusive license territory may be ``worldwide,'' and the field of use may be limited to: (1) The use of morpholino oligonucleotides that reduce expression of CD47 in combination with radiotherapy, to treat or prevent cancers in humans; and (2) the use of morpholino oligonucleotides that reduce expression of CD47 to treat or prevent radiation exposure damage in humans.
Government-Owned Inventions; Licensing and Collaborative Research Opportunity: Chemotoxins for Targeted Treatment of Diseased Cells
Document Number: 2011-31554
Type: Notice
Date: 2011-12-08
Agency: Department of Health and Human Services, National Institutes of Health
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Government-Owned Inventions; Availability for Licensing
Document Number: 2011-31553
Type: Notice
Date: 2011-12-08
Agency: Department of Health and Human Services, National Institutes of Health
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: 2011-31551
Type: Notice
Date: 2011-12-08
Agency: Department of Health and Human Services, National Institutes of Health
President's Committee for People With Intellectual Disabilities Notice of Committee Meeting via Conference Call
Document Number: 2011-31539
Type: Notice
Date: 2011-12-08
Agency: Department of Health and Human Services, Administration for Children and Families
Emergency Clearance: Public Information Collection Requirements Submitted to the Office of Management and Budget (OMB)
Document Number: 2011-31536
Type: Notice
Date: 2011-12-08
Agency: Department of Health and Human Services, Centers for Medicare and Medicaid Services
Nominations to the Advisory Committee on Blood Safety and Availability
Document Number: 2011-31534
Type: Notice
Date: 2011-12-08
Agency: Department of Health and Human Services
The Office of Assistant Secretary for Health (OASH) is seeking nominations of qualified individuals to be considered for appointment as members of the Advisory Committee on Blood Safety and Availability (ACBSA). ACBSA is a Federal advisory committee in the Department of Health and Human Services (HHS). Management support for the activities of this Committee is the responsibility of the OASH. The qualified individuals will be nominated to the Secretary of HHS for consideration of appointment as members of the ACBSA. Members of the Committee, including the Chair, are appointed by the Secretary. Members are invited to serve on the Committee for up to four-year terms.
Secretary's Advisory Committee on Heritable Disorders in Newborns and Children; Notice of Meeting
Document Number: 2011-31522
Type: Notice
Date: 2011-12-08
Agency: Department of Health and Human Services, Health Resources and Services Administration
Proposed Information Collection Activities; Comment Request
Document Number: 2011-31493
Type: Notice
Date: 2011-12-08
Agency: Department of Health and Human Services, Administration of Children and Families
Agency Information Collection Request; 60-Day Public Comment Request
Document Number: 2011-31468
Type: Notice
Date: 2011-12-08
Agency: Department of Health and Human Services
Biologics Price Competition and Innovation Act of 2009; Proposed Recommendations for a User Fee Program for Biosimilar and Interchangeable Biological Product Applications for Fiscal Years 2013 Through 2017; Notice of Public Meeting; Request for Comments
Document Number: 2011-31499
Type: Notice
Date: 2011-12-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a public meeting to discuss the proposed recommendations for a user fee program for biosimilar biological products for fiscal years (FYs) 2013 through 2017.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2011-31449
Type: Notice
Date: 2011-12-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2011-31445
Type: Notice
Date: 2011-12-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Request for Nominations of Candidates To Serve on the Board of Scientific Counselors (BSC), Office of Infectious Diseases (OID)
Document Number: 2011-31429
Type: Notice
Date: 2011-12-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2011-31407
Type: Notice
Date: 2011-12-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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